At its Pau site, FAREVA continues to drive pharmaceutical innovation with the opening of a new GMP sterile pilot unit dedicated to the production of liquid and lyophilized injectable forms.
An infrastructure tailored to market needs
With its new isolator, FAREVA now offers development services covering formulation and aseptic filling of liquid and lyophilized forms. This new production capability supports development studies, clinical trial material manufacturing, and the potential production of small commercial batches (e.g., pediatric or orphan drugs).
The equipment complies with the latest requirements of the revised Annex 1 on sterile products and enables the manufacturing of biotechnology-derived drugs such as monoclonal antibodies, mRNA in LNP form, proteins, peptides, recombinant proteins, and ADCs. It supports projects from Phase 1 to 3 and through to commercialization, thanks to FAREVA’s industrial network of 5 sterile sites.
FAREVA, a strategic partner for the pharmaceutical and biotech industries
Batch sizes are flexible, ranging from 200 to 8,000 vials, with the possibility to implement single-use systems. The isolator is designed to handle a wide range of products—from small molecules classified as OEB 1 to highly potent substances up to OEB 5—leveraging over 30 years of expertise at the Pau site.
The unit includes an aseptic preparation area for bulk formulation, connected to a 2 m² lyophilizer through a unidirectional airflow aseptic filling line, in full compliance with Annex 1 requirements. An autoclave completes the setup for products requiring terminal sterilization.
FAREVA Pau is also equipped with an integrated cold chain system, ensuring strict temperature control at every stage of the manufacturing process. This enables optimal storage of Drug Substances (DS), temperature maintenance of formulations prior to filling, and protection of Drug Products (DP) up to shipment.
The pilot unit benefits from the full support of the existing site infrastructure: Quality Assurance, EHS, Engineering, Logistics (procurement, cold chain), visual inspection, and packaging.
With this new capability, FAREVA continues to expand what's possible for its partners—delivering uncompromising pharmaceutical quality and full regulatory compliance.
We also provide support with analytical development services required for batch release, registration, validation, and stability studies.
Expert support for a faster time-to-market
With this new infrastructure, FAREVA strengthens its position as a key player in sterile Fill & Finish, offering pharmaceutical and biotech companies a high-performance, secure solution fully aligned with the latest regulatory requirements.